Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532838
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Optimized Strategies for Malperfusion Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimized Strategies for Acute Type A Aortic Dissection Complicated With MalPerfusion Syndrome OPTIMIZE-MPS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An investigator-initiated randomized multicenter two-arm open-label study of consecutive patients presenting with acute type A aortic dissection ATAAD and malperfusion syndrome MPS
Objectives The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies OTS versus traditional treatment strategies TTS for ATAAD patients with MPS
Background The mortality of ATAAD with MPS is high However the management strategies of MPS patients still not to be confirmed Compare with TTS OTS as a strategy for ATAAD patients with MPS might have be beneficial results
Objectives The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies OTS versus traditional treatment strategies TTS for ATAAD patients with MPS
Background The mortality of ATAAD with MPS is high However the management strategies of MPS patients still not to be confirmed Compare with TTS OTS as a strategy for ATAAD patients with MPS might have be beneficial results
Detailed Description:
A total of 236 subjects with ATAAD complicated with MPS who met inclusion criteria and do not have any exclusion criterion will be randomized to optimized treatment strategies OTS group and traditional treatment strategies TTS group
1 Patients randomized to OTS group will be treated with optimized treatment strategies The optimized strategies based on 6-hour threshold from symptom onset For malperfused patients with symptom onset within 6 hours central repair will be performed immediately Additional stenting will be used in patients with persistent malperfusion For malperfused patients with symptom onset beyond 6 hours individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair
2 Patients randomized to TTS group will treated with traditional treatment strategies Immediate central repair will performed for patients with coronary and cerebral malperfusion syndrome However for patients with mesenteric and lower extremity malperfusion syndrome interventional therapy will be administered through fenestration andor stenting to first alleviate organ ischemia Once the patients had a resolution of organ failure corrective open aortic repair will be performed
1 Patients randomized to OTS group will be treated with optimized treatment strategies The optimized strategies based on 6-hour threshold from symptom onset For malperfused patients with symptom onset within 6 hours central repair will be performed immediately Additional stenting will be used in patients with persistent malperfusion For malperfused patients with symptom onset beyond 6 hours individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair
2 Patients randomized to TTS group will treated with traditional treatment strategies Immediate central repair will performed for patients with coronary and cerebral malperfusion syndrome However for patients with mesenteric and lower extremity malperfusion syndrome interventional therapy will be administered through fenestration andor stenting to first alleviate organ ischemia Once the patients had a resolution of organ failure corrective open aortic repair will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None